NCT03090906

Soft Tissue Volume Gain and Stability Comparing Palate and Tuberosity

Clinical and Histological Analysis of Soft Tissue Volume Gain and Stability Around Dental Implants Using Autogenous Subepithelial Connective Tissue Grafts Harvested From the Palate or Tuberosity. A Randomized Controlled Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Universitat Internacional de Catalunya · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to compare clinical and histologically the soft tissue changes in terms of volume gain and stability around dental implants in cases where a subepithelial connective tissue graft from the palate or from the tuberosity is used randomly

Detailed description

Understanding the importance of the soft tissue around implants have lead clinicians to develop surgical approaches to augment it. The majority of them, are described as bilaminar techniques obtaining a subephitelial connective tissue graft (SCTG) from the palate (P). However, recent studies have demonstrated that tuberosity (T) tissue is a very dense and coarse tissue that seems to contain more collagen and less fat and glandular tissue than that from the P, and therefore may have better tissue qualities for soft tissue augmentation, but there is limited scientific evidence comparing these areas. The main goal of this study is to compare the soft tissue volume gain and stability around implants in cases where a SCTG of the same dimensions from the P or T is used randomly. To calculate volume changes and stability an intraoral optical scan is used and three-dimensional images superimposed. The secondary goal is to compare histologically both tissues and changes in clinical parameters. Histomorphometry and immunohistochemistry evaluating levels of Type I-III collagen, long lysyl hydroxylase, matrix metalloproteinase 1-2, and monoclonal antibody against cytokeratin 4-10-13 is performed.

Conditions

• Tooth Loss
• Recession, Gingival

Interventions

Type	Name	Description
PROCEDURE	Soft tissue augmentation palate	Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table. Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness. Palate (CG) The double incision was made approximately 2 to 3 mm apical to the gingival margins of premolars. The donor tissue was removed and cross-mattress sutures were used to approximate the wound on the palate. In both groups the epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick.
PROCEDURE	Soft tissue augmentation tuberosity	Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal flap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table. Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness. Tuberosity (TG) The double incision was made from the distal of the terminal tooth. A second incision was made perpendicular to the linear incision at a distal point, which joined the two linear incisions. The graft was removed and a crossed horizontal suspension suture was used. Epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick.
DEVICE	Intraoral optical scan	Intraoral optical scan was performed at both groups at baseline, 3 months, 4 months and 12 months to be able to compare volumetric changes.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-03-01
• Completion: 2017-08-01
• First posted: 2017-03-27
• Last updated: 2017-05-04